Women, those infected at young age, certain virus subtypes may not see great benefit from early therapy

Boston, MA - In the first analysis that takes into account the variety in progression of hepatitis C infection, researchers at Harvard School of Public Health’s Center for Risk Analysis looking at the clinical benefit and cost effectiveness of the latest treatment for the disease have concluded that early treatment may not be the right choice for many thousands of people with asymptomatic hepatitis C infection.

Their analysis is described in the July 9, 2003 issue of the Journal of the American Medical Association (JAMA) “Cost-Effectiveness of Treatment for Chronic Hepatitis C Infection in an Evolving Patient Population.”

Hepatitis C virus (HCV) is a largely asymptomatic disease that after a long latency period, usually spanning decades, can damage the liver and eventually cause cirrhosis and liver cancer. While it is currently a leading cause of liver transplantation in the U.S., many infected patients will never develop advanced liver disease. HCV infection is most commonly transmitted through shared needle use and also had been passed along through blood transfusions before testing of blood donations largely eliminated that route in the early 1990s.

The current treatment recommended for HCV is an injected long-acting interferon plus oral ribavarin. Treatment has improved considerably in the last decade but is still only effective in 40 to 60 percent of patients, has potentially severe side effects (e.g., nausea, severe fatigue, depression and, in some cases, suicidal impulses), and a single 48-week treatment course costs more than $20,000. Previous analyses have found that treating HCV is clinically beneficial and cost-effective, on average, in patients infected with HCV and with evidence of existing liver disease. For patients without evidence of liver damage, the effects of early therapy on life expectancy and particularly on patient quality of life are less clear.

In the United States an estimated 2.7 million individuals are chronically infected with HCV, but many of these people remain unaware of their infections. Rising interest in HCV from patient advocacy groups, public health advisory groups, and the lay press has been accompanied by a range of policy initiatives such as a government ‘lookback’ campaign launched in 1998 to notify people who received blood from potentially infected donors and an open letter from the Surgeon General in July 2000 warning the public about the ‘silent epidemic’ and encouraging at-risk individuals to get tested.

In this analysis, HSPH researchers, led by Joshua Salomon, assistant professor of international health, looked at a patient population of HCV seropositive but otherwise healthy individuals-- people with the mildest form of the disease and the group most likely to be turned up in larger numbers by the HCV testing campaigns. Additionally, the researchers examined the latest information on the progression of the disease in several subgroups of patient by gender, age and other factors. This data showed that progression is highly variable, and some 30 to 70 percent of infected individuals may never progress to liver cirrhosis before dying from other causes.

In women in particular HCV appears to progress especially slowly. The probability of developing cirrhosis during a 30-year period was estimated to be between 13 and 46 percent for men and between one and 29 percent for women. Progression rates to cirrhosis and its complications are probably also substantially lower among those individuals infected at relatively young ages.

“Taking into account this lowered assessment of risk for some groups, the possible toxic side effects of therapy, and the limited efficacy of current regimens, the benefits of early therapy may not outweigh the substantial costs and decreases in quality of life for some individuals,” said Sue Goldie, associate professor of health decision science and senior author of the paper. “As the pool of patients eligible for treatment expands to the more general population, it will be imperative for patients and their physicians to consider these factors in approaching treatment decisions at the individual level.”

“Policy makers need to carefully consider the implications that public health campaigns targeted at HCV will have on the individual clinical decisions that follow,” said Salomon. “There has been a huge effort over the last few years to identify people infected with HCV, but this wider group of patients will likely include those who are least likely to develop advanced liver disease. For patients at low risk of progressing, the overall health gain from treatment may be minimal given the potential for toxic side effects.”

The research was supported in part by a grant to Dr. Salomon from the former Agency for Health Care Policy and Research. Coauthors Drs. Goldie, Milton Weinstein and James Hammitt are members of the Harvard Center for Risk Analysis and the Department of Health Policy and Management at HSPH.

For further information, please contact:

Robin Herman
Director of Communications
Harvard School of Public Health
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Boston, Massachusetts 02115